FDA 的人用药品和生物制品获益-风险框架：在药物审批获益-风险评估和使用分析中的作用。
FDA's Benefit-Risk Framework for Human Drugs and Biologics: Role in Benefit-Risk Assessment and Analysis of Use for Drug Approvals.
机构信息
Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Silver Spring, USA.
, 10903 New Hampshire Ave, WO Bldg 51 Rm 1141, Silver Spring, MD, 20993, USA.
出版信息
Ther Innov Regul Sci. 2021 Jan;55(1):170-179. doi: 10.1007/s43441-020-00203-6. Epub 2020 Aug 10.
BACKGROUND
Structured, descriptive approaches are utilized by drug regulatory agencies to support and communicate approval decisions about human drugs and biologics. The US Food and Drug Administration (FDA) uses the Benefit-Risk Framework (BRF), which has been integrated into its drug review process. This paper reviews how FDA review teams have used the BRF to communicate approval decisions.
METHODS
This paper (1) uses content analysis to systematically review the decision factors communicated by FDA review teams in all BRFs associated with novel drugs approved by FDA in 2017-2018 and (2) presents a case study about how the BRF was used for three drugs approved for HIV-1 in 2018-2019.
RESULTS
The content analysis found most BRFs for novel drug approvals communicate what we call an "urgent" context and complicating decision factors around benefit and/or risk; the HIV-1 case study highlights the flexibility of the structured BRF tool.
CONCLUSIONS
FDA's BRF provides a flexible mechanism for communicating important decision factors, allowing it to support the diversity of drug approval decisions made by FDA.
背景
药物监管机构采用结构化、描述性方法来支持和传达关于人用药物和生物制品的批准决定。美国食品和药物管理局 (FDA) 使用了获益-风险框架 (BRF)，该框架已被纳入其药物审查流程。本文回顾了 FDA 审查团队如何使用 BRF 来传达批准决定。
方法
本文（1）使用内容分析法系统地审查了 2017-2018 年 FDA 批准的新型药物相关的所有 BRF 中 FDA 审查团队传达的决策因素，（2）介绍了一个案例研究，说明 BRF 如何用于 2018-2019 年批准的三种用于治疗 HIV-1 的药物。
结果
内容分析发现，大多数新型药物批准的 BRF 传达了我们称之为“紧急”背景的信息，并围绕获益和/或风险因素复杂了决策因素；HIV-1 案例研究突出了结构化 BRF 工具的灵活性。
结论
FDA 的 BRF 为传达重要决策因素提供了一种灵活的机制，使其能够支持 FDA 做出的各种药物批准决定。
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